NewsEMA restricts use of anti-PD-1 drugs for bladder cancer
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Cited by (27)
Nicotinamide phosphoribosyltransferase modulates PD-L1 in bladder cancer and enhances immunotherapeutic sensitivity
2024, Biochimica et Biophysica Acta - Molecular Basis of DiseaseRole of Bone Metastases in Patients Receiving Immunotherapy for Pre-Treated Urothelial Carcinoma: The Multicentre, Retrospective Meet-URO-1 Bone Study
2022, Clinical Genitourinary CancerCitation Excerpt :Immune-checkpoint inhibitors (ICIs) have an established role in mUC, particularly for the treatment of platinum-refractory disease and, more recently, in the maintenance setting after platinum-based chemotherapy. ICIs are also approved for patients who are ineligible for cisplatin in the first-line setting.8-18 Although clinical experience suggests a detrimental effect of BoM on outcomes in both first- and subsequent-lines treatments with ICIs,19 none of the published studies investigated the implication of bone involvement in patients exposed to immunotherapy.
Post-translational modifications in bladder cancer: Expanding the tumor target repertoire
2020, Urologic Oncology: Seminars and Original InvestigationsNeuroendocrine Carcinoma of the Urinary Bladder: A Large, Retrospective Study From the French Genito-Urinary Tumor Group
2020, Clinical Genitourinary CancerCitation Excerpt :Immunotherapy has shown promising results in the management of both SCLC and UC. Atezolizumab21,22 and pembrolizumab23 can be used as first- or second-line therapy in the management of metastatic UC.24 In addition, because of the high mutational burden, SCLC has been shown to benefit from immunotherapy with atezolizumab.25,26
Clinical outcome after progressing to frontline and second-line Anti–PD-1/PD-L1 in advanced urothelial cancer[Formula presented]
2020, European UrologyCitation Excerpt :In 2017, the European Medicines Agency (EMA) and the Food and Drug Agency (FDA) granted accelerated approval to atezolizumab and pembrolizumab for first-line metastatic cisplatin-ineligible UC based on single-arm phase II clinical trial data [7,8]. The label has recently been restricted by the EMA and FDA based on early preliminary data from ongoing first-line phase III clinical trials [9,10]. These unpublished data suggest reduced survival in mUC patients treated with frontline ICIs with low PD-L1 status (≤5% in tumor-infiltrating immune cells or <10% combined positive score, assessed by Ventana SP142 and Dako 22C3, respectively) when compared with chemotherapy.
Performance of the Food and Drug Administration/EMA-approved programmed cell death ligand-1 assays in urothelial carcinoma with emphasis on therapy stratification for first-line use of atezolizumab and pembrolizumab
2019, European Journal of CancerCitation Excerpt :Because these assays are expensive and not reimbursed by health insurances in several EU countries, this could lead to a widespread withholding of a potentially effective therapy. Furthermore, prior studies demonstrated that PD-L1 assays are not standardised, leading to different staining results potentially affecting appropriate treatment selection [12–16]. Interobserver effects might further affect appropriate therapy selection [17,18].